SERAQUEST EB NA IGG


Device Classification Name

epstein-barr virus, other

510(k) Number K991975
Device Name SERAQUEST EB NA IGG
Applicant
QUEST INTL., INC.
1938 n.e. 148th terr.
north miami, 
FL 
33181

Applicant Contact robert a cort
Correspondent
QUEST INTL., INC.
1938 n.e. 148th terr.
north miami, 
FL 
33181

Correspodent Contact robert a cort
Regulation Number 866.3235
Classification Product Code
LSE  
Date Received 06/11/1999
Decision Date 11/02/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No